Fulcrum Therapeutics’ Losmapimod Receives the US FDA’s Fast Track Designation to Treat Facioscapulohumeral Muscular Dystrophy

May 13, 2021 Auto Bot Fast Track Designation, regulatory, Us FDA 0

Shots:

  • The US FDA has granted FTD to losmapimod for the treatment of FSHD while the therapy has previously received ODD for FSHD
  • The company will present full data from the P-IIb ReDUX4 trial assessing losmapimod vs PBO in patients with FSHD at FSHD on June 24-25, 2021 that include 1EP results i.e., reduction from baseline of DUX4-driven gene expression and pre-specified sensitivity analysis assessing biopsies with the highest pre-treatment level of DUX4-driven gene expression
  • The additional 2EPs results i.e., disease progression via skeletal muscle MRI, exploratory EPs evaluate muscle function measures and patient-reported outcomes

Click here to­ read full press release/ article | Ref: Fulcrum Therapeutics | Image: Fulcrum Therapeutics

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